Acetaminophen; Butalbital; Caffeine Contraindications and Precautions
- abrupt discontinuation
- acetaminophen hypersensitivity
- agranulocytosis
- barbiturate hypersensitivity
- ethanol intoxication
- hepatic encephalopathy
- porphyria
- alcoholism
- anemia
- angina
- anticoagulant therapy
- asthma
- bone marrow suppression
- breast-feeding
- carbamazepine hypersensitivity
- cardiac arrhythmias
- cardiac disease
- children
- chronic obstructive pulmonary disease (COPD)
- CNS depression
- depression
- diabetes mellitus
- driving or operating machinery
- elderly
- exfoliative dermatitis
- G6PD deficiency
- head trauma
- hepatic disease
- hepatitis
- hydantoin hypersensitivity
- hypertension
- hypotension
- immunosuppression
- infants
- infection
- inflammatory bowel disease
- labor
- mental status changes
- myocardial infarction
- pain
- peptic ulcer disease
- pregnancy
- pulmonary disease
- renal disease
- renal failure
- renal impairment
- respiratory depression
- salicylate hypersensitivity
- seizure disorder
- seizures
- sleep apnea
- status asthmaticus
- status epilepticus
- substance abuse
- suicidal ideation
- thyroid disease
Acetaminophen; Butalbital; Caffeine Contraindications and Precautions
NOTE: This monograph discusses the use of acetaminophen-butalbital-caffeine combination products. Clinicians may wish to consult the individual monographs for more information about the specific contraindications and precautions for each agent.
Acetaminophen-butalbital-caffeine should not be used in patients with barbiturate hypersensitivity, or hypersensitivity to any of the other product components. Barbiturates can cause severe and potentially fatal reactions that are preceded by skin eruptions. Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of adverse hematologic (i.e., agranulocytosis), hypersensitivity, or other adverse reactions to barbiturate or other anticonvulsants. Skin reactions can precede potentially fatal hypersensitivity reactions; exfoliative dermatitis has resulted in fatalities. Hypersensitivity reactions have been reported in patients who previously experienced hydantoin hypersensitivity (e.g., phenytoin) or carbamazepine hypersensitivity. Estimates of cross-sensitivity vary, but may range from 30 - 80%. There is no way to predict with certainty which patients will exhibit cross-sensitivity.
Acetaminophen-butalbital-caffeine should not be used in patients with a known acetaminophen hypersensitivity. Acetaminophen hypersensitivity reactions are rare, but severe sensitivity reactions are possible.
Acetaminophen-butalbital-caffeine should not be used in patients with porphyria because it may trigger symptoms of the disease. Barbiturates can stimulate the accumulation of porphyrin precursors.
Acetaminophen-butalbital-caffeine should be used with caution in patients with mental status changes such as major depression or suicidal ideation due to exacerbation of these conditions by the CNS depressant effects. Acetaminophen-butalbital-caffeine should be prescribed cautiously to certain high risk patients such as elderly or debilitated patients, patients with cardiac disease (e.g., angina, cardiac arrhythmias, hypertension, hypotension, or immediately following a myocardial infarction) because of possible adverse hemodynamic effects. Elderly patients may experience increased side effects such as excitement, confusion or depression. In cases where an overdose of a barbiturate has occurred, symptoms may include: confusion, hypotension, incoherent speech, nystagmus, and tachycardia. According to US federal OBRA regulations, butalbital is not to be used in a nursing home patient, unless started before admission to the nursing home, or given as a single dose for a medical or dental procedure. Discontinuation should be gradually attempted at least twice in one year before discontinuation is considered ‘clinically contraindicated.’
Acetaminophen-butalbital-caffeine should be used carefully in patients with hepatic disease (e.g., alcoholic hepatic disease or viral hepatitis) as there is an increased risk for developing drug toxicity. Acetaminophen should not be used in patients who consume 3 or more alcoholic beverages per day. Hepatically-impaired patients may require lower dosage and slower dosage titration; avoid butalbital in patients with severe liver impairment. Because barbiturates may impair the ability of the liver to metabolize ammonia, barbiturates are best avoided in patients with hepatic encephalopathy. Note that barbiturates are hepatic enzyme inducers and patients should be monitored for altered drug levels and therapeutic effects as indicated (see Drug Interactions). Acetaminophen-butalbital-caffeine should also be used carefully in patients with diabetes mellitus, inflammatory bowel disease, peptic ulcer disease, renal disease, renal failure, renal impairment, or thyroid disease. Liver and/or renal function tests may need to be monitored.
Because butalbital can cause dose-dependent respiratory depression, it should be used cautiously in patients with pulmonary disease states causing respiratory depression, dyspnea, severe pulmonary insufficiency or airway obstruction. Barbiturates should be avoided in patients with bronchopneumonia. Use with close supervision in patients with sleep apnea or chronic obstructive pulmonary disease (COPD). Avoid butalbital use in patients with status asthmaticus or asthma. Acetaminophen should be used cautiously in patients with asthma who also have salicylate hypersensitivity. Of 50 patients with aspirin-sensitive asthma, 17 had either a naso-ocular or bronchospastic reaction after ingestion of either 1000 mg or 1500 mg of acetaminophen. The magnitude of FEV1 decline after a mean aspirin dose of 47 mg was similar to the decline seen after a mean acetaminophen dose of 1227 mg. The lower the aspirin provocative dose, the more likely patients were to cross-react to acetaminophen. For example, 5 of 6 patients with aspirin-induced bronchospasm after a dose of 30 mg or less had cross-reactivity to acetaminophen whereas no patients had cross-reactivity when the provocative aspirin dose was at least 150 mg. The acetaminophen challenges were performed before any aspirin challenges and all patients had a measured FEV1 of at least 70% of predicted or best previously recorded value, an absolute value greater than 1.5 liters, and a fall of less than 15% in FEV1 from morning baseline during placebo challenges.
Acetaminophen-butalbital-caffeine should be used with caution in patients with head trauma. The CNS depressant effects of butalbital may further obscure the clinical course of head injury patients. Butalbital may cause blurred vision, drowsiness, or dizziness, especially with initial use. Patients should use caution when driving or operating machinery until they are aware of the effects of the drug. Ethanol intoxication or concomitant use of other sedating drugs can magnify CNS depression and is best avoided. Avoid use of butalbital in patients with alcoholism; seizure activity may be induced.
Patients with G6PD deficiency who overdose with acetaminophen may be at increased risk for drug-induced hemolysis. During acetaminophen overdose, cyanosis may not be apparent in patients with pre-existing anemia, in spite of dangerously high blood concentrations of methemoglobin.
Acetaminophen-butalbital-caffeine combinations are classified as FDA pregnancy-risk category C and should be used during pregnancy only if the benefits to the mother outweigh the potential risks to the fetus. All three components cross the placenta. There have been reports of physical abnormalities in infants correlating to exposure to barbiturates in utero. Additionally, a retrospective study revealed that in utero exposure to barbiturates was associated with intelligence deficits. Repeated use of butalbital during the third trimester can also cause physical dependence in the neonate. A withdrawal seizure has been reported in a 2-day old infant whose mother had been taking a butalbital-containing medication during the last 2 months of her pregnancy. If the mother used butalbital late in pregnancy, newborns should also be carefully observed for signs of ventilatory depression, particularly if the infant is premature. There is no established use for butalbital during labor or obstetrical delivery. Neonatal arrhythmias (e.g., tachycardia, premature atrial contractions) and tachypnea have been reported when caffeine was consumed during pregnancy in amounts > 500 mg/day. Caffeine withdrawal in the neonate after birth may account for these symptoms. Fatal arrhythmias in neonates with caffeine use by the mother have also been reported. Females should be warned of the potential adverse effects on the fetus should pregnancy occur while taking acetaminophen-butalbital-caffeine combinations.
Acetaminophen-butalbital-caffeine components may all be excreted to some extent into breast milk. Caffeine can accumulate in the neonate. Chronic barbiturate use while breast-feeding may cause dependence in the neonate. The chronic use of acetaminophen-butalbital-caffeine during breast-feeding is not recommended.
The safety and efficacy of acetaminophen-butalbital-caffeine combinations have not been established in children.
Symptoms of acute infection (e.g., fever, pain) can be masked during treatment with acetaminophen in patients with bone marrow suppression or immunosuppression.
Acetaminophen-butalbital-caffeine combinations should be prescribed with caution to patients with known substance abuse because of the potential for psychological and/or physical dependence to butalbital. Avoid abrupt discontinuation of butalbital after prolonged use to limit drug withdrawal and/or seizure onset. Sudden, abrupt discontinuation of butalbital in epileptic patients may precipitate acute seizures, status epilepticus, or other seizure disorder.
Patients taking warfarin (Coumadin®) anticoagulant therapy may not be appropriate candidates for acetaminophen; butalbital (see Drug Interactions).
[ Last revised: 4/5/2004 4:22:00 PM ]
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